With over 25 years of experience, Dr. Shieh-Newton plays a strategic role for her clients as she guides their patent strategy, portfolio management and investments. Trained as an immunologist at Johns Hopkins School of Medicine, where she earned a PhD in Cellular and Molecular Medicine, she works with companies of all sizes in a wide range of life sciences, including Artificial Intelligence in life sciences and synthetic biology industries. She also has conducted hundreds of IP due diligence for companies and investors at all stages of investment. Dr. Shieh-Newton is known for her creative, business-savvy solutions and strategic thinking.
Dr. Shieh-Newton has significant experience in a wide range of life sciences, synthetic biology, and clean technology industries that allows her to provide creative solutions and render pragmatic business advice to her clients. Her practice focuses on global patent strategy, creation of valuable IP portfolios, preparation and prosecution of patent applications, comprehensive portfolio management, freedom-to-operate analysis, opinion work, inter partes review (IPR) and other post-grant proceedings, and complex landscape searches and white space analysis.
Dr. Shieh-Newton leads and conducts due diligences for both private and public companies and investors. Dr. Shieh-Newton has been the primary IP counsel on many deals on behalf of investment bankers and underwriters for IPOs and other capital market offerings totaling >$2 billion. Dr. Shieh-Newton has also worked on company-side reverse mergers, public offerings and mergers & acquisitions. She has also worked with private equity firms, hedge funds, and venture capitalists on due diligence assessment for investments and landscape analysis for formation of new funds and companies.
In addition, Dr. Shieh-Newton’s practice includes assessing freedom-to-operate positions and rendering patentability and invalidity opinions. She has extensive experience in evaluating patent landscapes to advise clients seeking to enter competitive markets, as well as advising clients on third-party challenges and risk mitigation strategies. Dr. Shieh-Newton has worked on biotechnology patent litigations, oppositions, and inter partes reviews.
Dr. Shieh-Newton has worked on a wide variety of technical areas including antibodies, biologics and biosimilars, immuno-oncology (including chimeric T-antigen receptors and engineered immune cells), immunotherapy, cell therapy, gene editing (e.g., CRISPR technology), stem cells, regenerative medicine, gene therapy, synthetic biology, microbiomes, enzymes, protein engineering, protein production and therapeutics, vaccines and adjuvants, diagnostics and biomarkers, cancer, biofuels, microbial & yeast engineering, industrial fermentation, production of target chemical using biological processes, quantum sensors, biological computations units, and artificial intelligence/machine learning for life science applications amongst other subject matters.
Dr. Shieh-Newton has worked with emerging companies, universities, as well as larger companies. Representative matters include work done for Roche, Genentech, 10x Genomics, DuPont/Danisco/Genencor, Regeneron, Ariosa, University of California, and Stanford University.
Dr. Shieh-Newton was trained as an immunologist at Johns Hopkins School of Medicine, where her doctoral research focused on natural killer cells and the early immune responses to HIV and SIV infection. Dr. Shieh-Newton was a student fellow with Nobel Laureates Dr. Joseph Goldstein and Dr. Michael Brown, researching farnesylated ras proteins.
In 2023, Dr. Shieh-Newton earned a certificate in Artificial Intelligence in Pharma and Biotech from MIT Sloan School of Management.
Dr. Shieh-Newton is in leadership positions at the firm, currently serving on the firm’s Policy Committee (i.e., Executive Committee). She founded and is co-chair of the firm’s AI Life Sciences IP group. She also serves as co-chair of the Minority Attorneys & Agents affinity group and serves on the Equity Advisory Committee and Women’s Initiative Steering Committee.
Dr. Shieh-Newton was recognized on the Chambers USA list for Patent Prosecution (2022 - 2024), LMG Life Science’s “Patent Strategy Attorney of the Year – California” (2023), selected as one of the Top 250 Women in IP by Managing Intellectual Property (2022 - 2024), named to the National Law Journal's Intellectual Property Trailblazers list and also as a finalist for MIP's National Practitioner of the Year - Patent Prosecution. She has also been recognized as among the “100 Most Influential Women in Business in the Bay Area” by the San Francisco Business Times, identified annually among the “World’s Leading Patent Practitioners” in Intellectual Asset Magazine’s Patent 1000, and recognized in The Legal 500 “United States for Healthcare: Life Sciences.”
viewpoints
Biosimilars Webinars: A Five-Part Legal and Regulatory Issues Series
December 15, 2015 | Blog | By Terri Shieh-Newton, Joanne Hawana
Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101
June 24, 2015 | Alert | By Terri Shieh-Newton
Fed Circuit: Sequenom’s Diagnostic Method Claims Invalid Under §101
June 15, 2015 | Blog | By Terri Shieh-Newton
District Court Rules Against Amgen's Motion for Preliminary Injunction to Prevent Marketing of Sandoz's Biosimilar Zarxio
March 20, 2015 | Blog | By Thomas Wintner, Terri Shieh-Newton
“Why, I declare” … Proper Use of Evidentiary Declarations under New (Post-AIA) Rule 37 C.F.R. 1.130
October 30, 2014 | Advisory | By Terri Shieh-Newton
News & Press
Mintz IP Practice Recognized in 2024 IAM Patent 1000
June 18, 2024
Our Intellectual Property Practice earned national recognition in the 2024 edition of IAM Patent 1000 – The World’s Leading Patent Practitioners. The guide recognized Mintz with four firm-wide rankings and 14 individual attorney recommendations, including a gold ranking for Intellectual Property Chair Michael Renaud.
Mintz announced today that 42 of its practices and 83 of its attorneys earned recognition in the 2024 edition of Chambers USA, a guide to the country’s leading law firms. Of those included in the guide, 18 attorneys and seven practice areas were awarded Chambers’ highest ranking, Band 1. The firm obtained new listings in three practice areas and 10 of its lawyers were recognized for the first time.
Startups Are Using AI to Predict Responses to Cancer Drugs
December 28, 2023
San Francisco Member Terri Shieh-Newton, PhD spoke to the Wall Street Journal about the use of AI in the life sciences industry, specifically on how biomedical startups are using AI to predict patient responses to cancer treatments. Terri noted that while AI allows researchers to pull diverse sets together, humans must make careful decisions about the data sets they use to train the algorithms.
How Pharma Leaders Talk About Ethics in a Highly Criticized Industry
November 9, 2023
Member Terri Shieh-Newton, PhD spoke to PharmaVoice about ethical issues in the biopharma industry, particularly as artificial intelligence presents new challenges around safeguarding data and privacy.
Trio Of Attorneys Honored At 2023 LMG Life Sciences Americas Awards
September 08, 2023
Mintz is pleased to announce that life sciences practitioners from our US and Canada offices were honored at the 2023 LMG Life Sciences Americas Awards.
Health care organizations deploying AI face complex questions involving diversity, regulations, and ownership of innovations made with AI tools. In an interview with Healthcare IT News, Mintz Member Terri Shieh-Newton shared insights for providers on managing machine learning integration of racial diversity, gender, and genetic information and identifying inventorship of IP developed with AI.
In a Q&A with MobiHealthNews, Member Terri Shieh-Newton discussed intellectual property and AI, and shared her thoughts on what companies should think about when determining ownership of intellectual property.
BOSTON, MA – In the 2023 edition of 'IP Stars,' published by Managing Intellectual Property (Managing IP), Mintz achieved recognition in two nationwide categories and received acknowledgment for the exceptional performance of nine of its attorneys.
SAN FRANCISCO – Mintz is proud to announce that the National Law Journal named Member Terri Shieh-Newton, Ph.D., a nationally recognized IP attorney and a leading woman in the life sciences industry, a 2023 Intellectual Property Trailblazer. The IP Trailblazers list recognizes professionals working as agents of change in their practice areas.
BOSTON– Mintz’s award-winning Intellectual Property (IP) Practice again earned national recognition in the 2023 edition of IAM Patent 1000 – The World’s Leading Patent Practitioners. The guide recognized Mintz with three firm-wide rankings and 10 attorneys received a total of 11 individual recommendations.
BOSTON – Mintz has earned top rankings in the 2023 edition of Legal 500 United States guide. The firm is recognized in 14 practice categories, and 59 individual attorneys are also recognized in the guide, some in more than one category.
BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.
Managing Intellectual Property Names Terri Shieh-Newton To 2023 “Top 250 Women in IP”
April 28, 2023
SAN FRANCISCO – Mintz is pleased to announce that Member Terri Shieh-Newton, Ph.D., a nationally recognized IP attorney and a leading woman in the life sciences industry, has once again been selected for inclusion in the 2023 “Top 250 Women in IP” list by Managing Intellectual Property.
Mintz Advises Underwriters of Viking’s $287.5 Million Public Offering of Common Stock
April 10, 2023
NEW YORK – Mintz represented the syndicate of underwriters led by William Blair & Company, L.L.C., in the public offering of 17,242,000 shares of common stock of Viking Therapeutics, Inc. (“Viking”) (Nasdaq: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, at an initial offering price of $14.50 per share.
Second Wave Of Biosimilar Cases Sharpens Patent Counsel Focus
January 27, 2023
Member Terri Shieh-Newton spoke to Managing IP about the potential rise of biosimilar patent litigation in the U.S.
Artificial Intelligence and Intellectual Property
August 19, 2022
Mintz Creates Equity Advisory Council To Drive The Firm’s Commitment To Equity In Workplace
May 16, 2022
Mintz continues its ongoing commitment to ensuring the firm is an equitable workplace, establishing a new Diversity, Equity and Inclusion (DEI) committee that reports directly to the firm's main decision making body, the Policy Committee. The new Equity Advisory Council (EAC) will be responsible for driving equity for the firm’s attorneys, especially women, attorneys of color and LGBTQ+ attorneys.
Mintz is pleased to share that two attorneys and the firm’s Patent practice have been shortlisted in the 2022 edition of Managing Intellectual Property’s (MIP) Americas Awards. The awards recognize the “remarkable achievements and developments” of firms, individuals and companies impacting the IP sector over the past year.
Women, Influence & Power in Law 2020: Terri Shieh-Newton
October 29, 2020
Mintz Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States
June 12, 2020
Locking Down the IP Community
March 18, 2020
Women Increase Share of US Patents, But Only to 12 Percent
February 12, 2019
Subject Matter Eligibility Under 35 U.S.C. § 101 – Life Sciences
June 1, 2016
Events & Speaking
Third Annual Bay Area Diversity Event: Mentoring & Sponsorship for Success and Happiness
Domenico Winery
Empowering Women Change-Makers in The Synthetic Biology Industry
Mission Bay Conference Center, San Francisco
Protecting Your IP in the Age of the Collaborative Economy
San Francisco Center for Economic Development
San Francisco, CA
With over 25 years of experience, Dr. Shieh-Newton plays a strategic role for her clients as she guides their patent strategy, portfolio management and investments. Trained as an immunologist at Johns Hopkins School of Medicine, where she earned a PhD in Cellular and Molecular Medicine, she works with companies of all sizes in a wide range of life sciences, including Artificial Intelligence in life sciences and synthetic biology industries. She also has conducted hundreds of IP due diligence for companies and investors at all stages of investment. Dr. Shieh-Newton is known for her creative, business-savvy solutions and strategic thinking.
Recognition & Awards
Finalist for Managing Intellectual Property's National Practitioner of the Year – Patent Prosecution (2022, 2024) & named Patent Star (2024)
Recognized as one of the Top 250 Women in IP by Managing Intellectual Property (2022 - 2024)
Winner of Patent Strategy Attorney of the Year – California in LMG Life Sciences (2023)
Named in the National Law Journal as an Intellectual Property Trailblazer (2023)
Recognized in Chambers USA: California – Intellectual Property: Patent Prosecution (2022 - 2024)
Listed on IAM Patent 1000 “World’s Leading Patent Practitioners” (2020 - 2023)
Recognized by The Legal 500 United States for Healthcare: Life Sciences (2019 – 2023)
Recognized in Business Today's list of 10 Most Influential Intellectual Property Attorneys in California for Patent Prosecution (2023)
Selected as law firm honoree in the Collaborative Leadership category of Corporate Counsel’s Women, Influence & Power in Law Awards (2020)
Selected as one of the 100 Most Influential Women in Business in the Bay Area by the San Francisco Business Times (2020)
